Purpose.The
National Heart, Lung, and Blood Institute (NHLBI) invites applications to
participate in the NHLBI Progenitor Cell Biology Consortium. The goal of
the Consortium is to identify and characterize progenitor cell lineages, to
direct the differentiation of stem and progenitor cells to desired cell fates,
and to develop new strategies to address the unique challenges presented by the
transplantation of these cells. The Consortium will assemble clusters of
synergistic research projects, each with a multi-disciplinary team of Principal
Investigators, to establish virtual Research Hubs focused on progenitor cell
biology. The Consortium will also contain core research support
facilities and skills development components.

Research
Hub applications must consist of a cluster of two
to four synergistic applications, each of which must derive from a separate R03
application funded through RFA-HL-08-012.One of the applications must be designated the Lead PI/PD application.

Mechanism of Support. This FOA will utilize
the Research Project Cooperative Agreement (U01) mechanism of support.

Funds Available and Anticipated Number
of Awards. The NHLBI
intends to commit approximately $10 million total costs for FY2009. The total
amount to be awarded for the Consortium will be a maximum of $70 million total
costs for the seven-year project period. It is anticipated that 6 Research
Hub awards will be made through this FOA. Additional funds will be
available through a separate FOA to fund an Administrative Coordinating Center, cores and pilot projects to be administered by the ACC (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-005.html).

Budget
and Project Period.
The total project period for an application submitted in response to this FOA
is 7 years. Maximum allowable direct costs are $750,000 per
year for each U01 application in the Hub.

Eligible Project Directors/Principal
Investigators (PDs/PIs).TO
BE ELIGIBLE TO APPLY TO THIS FOA, PDs/PIs MUST HAVE BEEN PART OF AN R03
AWARD IN RESPONSE TO FOA HL-08-012 (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-08-012.html),
AND MUST ALSO HAVE PARTICIPATED IN THE DECEMBER 15, 2008, GRANTEES MEETING
IN BETHESDA, MARYLAND. Individuals with the skills, knowledge, and
resources necessary to carry out the proposed research are invited to work
with their institution/organization to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH
support.

Number of Applications.Applicants
may submit only one application as PI/PD; participation in additional
applications as co-investigator is permitted provided they are
scientifically distinct. Only one Lead PI /PD application, and only
two U01 applications in total, may be derived from any R03 application
(i.e. one Lead PI/PD application and one non-Lead, or two non-Lead PI/PD
applications Applicants to this FOA may not be part of an application to
the Consortium Administrative Coordinating Center (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-005.html).

Resubmissions. Resubmission
applications are not permitted in response to this FOA.

Renewals.Renewal
applications are not permitted in response to this FOA.

The National Heart,
Lung, and Blood Institute (NHLBI) invites applications to participate in the
NHLBI Progenitor Cell Biology Consortium. The goal of the Consortium is
to identify and characterize progenitor cell lineages, to direct the
differentiation of stem and progenitor cells to desired cell fates, and to develop
new strategies to address the unique challenges presented by the
transplantation of these cells. The Consortium will assemble clusters of synergistic
research projects, each with a multi-disciplinary team of Principal Investigators,
to establish virtual Research Hubs focused on progenitor cell biology. The
Consortium will also contain core research support facilities and skills development
components.

At present, a number of promising discoveries,
technologies, and reagents are poised to have a catalytic effect on the field
of regenerative biology and medicine. The aim of this initiative is to
markedly accelerate progress by forming a coordinated Consortium that includes
leading scientists in the field of cardiovascular, pulmonary and hematopoietic
cell biology, working closely with experts in the general field of progenitor
cell biology. Additional expertise in areas such as immunology,
developmental biology, bioengineering, animal model development, and imaging
will also be required to develop and translate these technologies. The goal of
the Consortium will be to harness advances in stem cell and progenitor cell
biology to improve the understanding and treatment of cardiovascular, lung, and
blood diseases. Areas of emphasis are expected to include lineages
derived from murine, human, and other embryonic stem cells, progenitor cells,
somatic stem cells, and induced pluripotent stem (iPS) cells (somatic cells
reprogrammed to become pluripotent), which are all included in the progenitor
cell biology Consortium described in this FOA. In addition, the
derivation of iPS cells from patients with genetic diseases, and
differentiation of these cells to specific cell types, is expected to give
unique mechanistic insight into disease processes. The development of
allogeneic cell lines offers the promise of faster, simpler, and cheaper
regenerative therapies, but brings new challenges in understanding immune
tolerance and therapy to prevent rejection. The generation of publicly
available molecular, epigenetic, and functional databases on specific embryonic
stem cell lines, induced pluripotent cells, and progenitor lineages will also
be a priority. Participants in the Consortium will be expected to share
data and resources with the Consortium rapidly in order to promote the goals of
the Consortium.

The research emphasis within the Consortium will vary
depending upon the status of stem and progenitor cell science. NHLBI
recognizes that fundamental knowledge of cardiovascular and pulmonary stem and
progenitor cell biology, including progenitor cell lineages, lags behind the
level of understanding in the hematopoietic field. Therefore, an area of
emphasis is the generation of well-characterized cardiovascular and lung
progenitor cell fate maps, integrated with specific approaches to identify,
purify, renew, and direct the differentiation of specific lineages of
interest. Another important focus will be regional and/or developmental
differences in cell origin and lineage, for example proximal versus distal lung
versus upper respiratory tract, and the identification of appropriate
phenotypic markers to facilitate these studies. For hematopoietic
studies, the de novo generation of hematopoietic stem cells (HSC) will be a key
objective, taking advantage of established stem cell markers, models and
reagents. Accomplishment of this goal has clear clinical implications
given the uses of HSC for transplantation. The combination of
cardiovascular, pulmonary, and hematopoietic cell biology within the Consortium
is seen as a clear advantage anticipated to accelerate progress in all three
areas. The Consortium is expected to foster innovative new technologies,
reagents, strategies, and protocols that will have a major impact on
scientific, translational, and clinical utility of cardiovascular, lung, and
hematopoietic progenitor cell lineages.

Derive induced pluripotent stem (iPS) cells from
patients with unique genotypes to permit differentiation to hematopoietic,
pulmonary, and cardiovascular cell types of interest for characterization
of disease mechanisms and to identify molecular inducers that correct
genetic networks. Develop new technologies to bypass the use of
oncogenes for reprogramming and avoid retroviral vectors carrying the risk
of insertional mutagenesis. Examples of alternative strategies may
include transient gene expression vectors and engineered
membrane-permeable transcription factor proteins or small molecules.

Develop new strategies to address the unique
challenges presented by the transplantation of allogeneic progenitor
cells, including approaches to deal with cell rejection, immune
surveillance and tolerance, cell survival, matrix interactions, and
integrated/functional grafting.

Identify, trace, purify, renew, and direct
differentiation of specific lung, cardiac, and vascular progenitor
lineages with state of the art technology from mouse and human sources.

Determine the genetic and epigenetic state of iPS
cells and define the network of genes (1) maintaining pluripotent stem
cells in an undifferentiated state; (2) regulating development of stem and
progenitor cells from pluripotent stem cells, e.g., iPS cells; and (3)
maintaining the stem or progenitor cells population.

Characterize and compare specific heart, lung, and
blood stem or progenitor cells from mouse and human sources by
transcriptional, FACS, epigenetic, and functional analysis, with a
particular interest in novel approaches for functional evaluation
employing tools of nanotechnology, bioengineering, and tissue engineering.

The goal of this FOA is to develop a highly interactive
and synergistic Consortium of investigators who will share ideas, data and
resources to move the field of progenitor cell biology forward. The Consortium
will consist of virtual Research Hubs formed from clusters of synergistic research
projects funded through this FOA, and an Administrative Coordinating Center
(ACC) supporting the Consortium funded through a separate FOA, http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-005.html.
The ACC will also administer funds to support cores, pilot studies, and
ancillary and collaborative studies.

Research Hub Structure

To foster new collaborations and facilitate partnerships
among different disciplines, applications will be submitted as two to four clustered
grant applications, each derived from separate R03 applications submitted in
response to FOA RFA-HL-08-012.
Within each cluster, a lead PI/PD must be identified who will be the point of
contact and will represent the Hub to NHLBI staff. PI/PDs of other
application(s) in the cluster will be collaborating PI/PDs. A minimum of 3
calendar months effort is required for the lead PI/PD, and a minimum 2.4
calendar months effort is required for the PI/PDs of the collaborating grants
in the Hub.

The Hub of applications must clearly describe the
management of the collaborative research. To ensure this, they must include a
management plan and identify a scientific oversight committee. The management
plan will:

Outline plans and mechanisms to keep the project
focused and progressing.

Set intermediate milestones on a timeline to allow
for the evaluation of progress towards the project's goal.

Explain how collaborators can be added or removed as
the expertise, knowledge, and skills necessary to advance the project
change.

Describe how intellectual property issues will be
handled.

Each Hub of applications must identify a scientific oversight
committee, consisting of those individuals identified in the management plan,
who together would have the intellectual and leadership responsibilities for
the collaborative research project normally attributed to the PI/PD. At a
minimum, the oversight committee must have a representative from each
collaborating application in the Hub. Funds should be budgeted for administering
the scientific oversight committee and activities noted in the management plan.

Consortium Structure

The Consortium will consist of multiple clusters of
applications, each forming a virtual Research Hub. In addition to
interactions within Research Hubs, extensive collaboration between Hubs is
expected. The Consortium will be supported by an ACC to provide
logistical support to the Consortium activities.

ACC: The ACC will serve a range of functions such as
organizing meetings; arranging teleconference calls of the Steering Committee,
External Advisory Committee, and Consortium annual meeting; and designing and
maintaining written materials and websites to support the Consortium. The
ACC will be responsible for solicitation of applications for cores, pilot
studies, and collaborative and ancillary studies. The ACC will oversee the
review and award of pilot/ancillary study funds for the Consortium, award
subcontracts for Cores, and coordinate the submission of progress reports by
the awardees for review by the External Advisory Committee and NHLBI staff.
The ACC will also coordinate skills development activities.

Cores: Cores, such as a cell processing
core, or an imaging core, will provide resources and services to multiple
Research Hubs. Requirements for Cores in the Consortium will be evaluated
once the Consortium has been established. The NHLBI, with input from the
External Advisory Committee, will determine the Core configuration, and the ACC
will allocate funds accordingly. Cores will initially be funded for two years,
and may be phased in and out based on scientific need during the course of the
research projects.

Pilot
Studies: A
major goal of the NHLBI Progenitor Cell Consortium is to foster highly
innovative, high-risk approaches that are not easily funded by traditional
mechanisms and that have the potential for unusually high impact to
significantly advance the field. Hence, pilot studies will be supported
for a maximum of two years at $100,000 direct costs per year. Solicitations
for pilot studies will be initiated beginning in Year 2 by the ACC. Pilot
studies that bridge between two or more Consortium Research Hubs will be given
higher priority in order to enhance the development of synergies between
Consortium investigators. The pilot studies are also expected to be helpful in
developing young investigators. The External Advisory Committee will be
responsible for peer review of these new pilot studies. Progress on these
studies will be monitored by program staff.

Ancillary
and Collaborative Studies: As the resources and programs develop, it is
anticipated that new opportunities will arise that will need additional
expertise from outside the Consortium or require new collaborations with other
members of the Consortium. To meet this need, funds will be made available
through the ACC to fund ancillary and collaborative studies awards. Solicitations
for ancillary and collaborative studies will be initiated by the ACC beginning in
Year 2 of funding. Expedited peer review by the External Advisory Committee
will be used to facilitate flexibility and rapid funding of ancillary studies. Progress
on these studies will be monitored by NHLBI staff.

Steering
Committee: The Consortium
will have a Steering Committee that will be responsible for overall scientific
direction, coordination and oversight. The Steering Committee will be
composed of the Lead PIs for each Research Hub, the ACC PI, and the NHLBI
Project Scientist. The Steering Committee will be chaired by an investigator
selected by the NHLBI. The Steering Committee will meet in person for an
implementation meeting at the start of the project period, by conference call
at least quarterly, and in person at least twice a year throughout the project
period.

Skills
Development Committee: A Skills Development Committee, composed of an
investigator from each Research Hub and from the ACC, will develop and coordinate
activities between the Research Hubs to enhance skills development for graduate
students, postdoctoral fellows, and young faculty. Each application
should identify a Skills Development Coordinator, whose relevant experience is
well documented in the Research Plan. Skills development activities will be
developed across the Consortium after funding, and do not need to be specified
in the application.

External
Advisory Committee: An External Advisory Committee (EAC) will oversee the Consortium.
The Committee will consist of non-Consortium affiliated scientists and other
experts appointed by the NHLBI to provide annual reviews of progress, and serve
as the peer review panel for pilot studies, ancillary and collaborative
studies, and cores.

Support for Skills Development: Full implementation
of a nationwide effort in progenitor cell research requires the availability of
MD, MD/PhD, and PhD scientists capable of independent research careers and
equipped with the leading experimental strategies and techniques to address the
outstanding questions in the field. Hence, a unique feature of the
Consortium is to support and develop promising new researchers with advanced
skills required to conduct research using state-of-the-art technologies and
approaches. These can be investigators beginning their research careers
or established investigators who are new to the application of the relevant disciplines
to the mission areas of the NHLBI. Applicants should budget into their
applications support for investigator skills development to be supported by the
Consortium for up to 2 years, during which time it will be expected that the
supported investigator will apply for NIH training or research grants to
continue supporting the research initiated through the Consortium. In
this way, Consortium funds will be available for additional new investigators
on a continuous basis to optimize the number of MD, MD/PhD, and PhD scientists
developed by the program. Supported investigators will be encouraged to
rotate through different laboratories in order to learn new skills, and to
facilitate this process each application should identify a Skills Development
Coordinator.

Annual Grantee Meeting: Upon initiation of
the program, the ACC on behalf of the NHLBI will arrange annual meetings to
encourage the exchange of information among the investigators who participate
in this program. In the preparation of the budget for the grant application,
applicants should include travel funds for one meeting each year to be held in
or near Bethesda, MD, for the Principal Investigators and key collaborators. At
these meetings awardees will be expected to share their results and to help
evaluate the progress of the Centers. Attendance at these meetings is
required.

This funding
opportunity will use theResearch
Project Cooperative Agreement (U01)award
mechanism(s). In the cooperative agreement mechanism, the Project Director/Principal
Investigator (PI/PD) retains the primary responsibility and dominant role for
planning, directing, and executing the proposed project, with NIH staff being
substantially involved as a partner with the Principal Investigator, as
described under the Section VI. 2. Administrative
Requirements, "Cooperative Agreement Terms and Conditions of Award."This is a
one-time solicitation to fund the Progenitor Cell Biology Consortium Administrative Coordinating Center for seven years. The Consortium will undergo a
mid-course review by the External Advisory Committee during the fourth year of
funding to determine how well the Consortium is meeting its goals.
Continued funding for individual progenitor cell biology research projects
funded through this FOA, and for the ACC funded through FOA http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-005.html,
will be contingent on the outcomes of this review. Metrics to be assessed in
the review of the research projects will include how well they are achieving
the milestones proposed in the research plan, productivity, contributions to
the overall goals of the Consortium, and data sharing. Continuation of this
program at the end of the seven years will depend on evaluations conducted by
the External Advisory Committee, NHLBI strategic priorities, and available
funds.

The estimated amount of
funds available for support of 6Research Hubs awarded as a
result of this announcement is $10 million for fiscal year 2009. Future year amounts will
depend on annual appropriations.

The
total amount of funding that the NHLBI expects to award through this
announcement is $70 million for a
project period of seven years.

The
expected direct cost amount for the Consortium awards will be up to $750,000
per year. The ACC
will also administer a budget for shared consortium cores, ancillary and
collaborative studies, and pilot studies funded through the Consortium ACC
FOA, as noted.

Because the nature
and scope of the proposed research will vary from application to application,
it is anticipated that the size and duration of each award will also vary.
Although the financial plans of the IC(s) provide support for this program,
awards pursuant to this funding opportunity are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.

Facilities and administrative costs requested by Consortium
participants are not included in the direct cost limitation; see NOT-OD-05-004.

Applicants
are not permitted to submit a resubmission application in response to this FOA.

Renewal applications are not permitted in
response to this FOA.

TO BE ELIGIBLE TO APPLY TO THIS FOA, PDs/PIs
MUST HAVE BEEN PRINCIPAL INVESTIGATOR OR CO-INVESTIGATOR ON AN R03 AWARD FUNDED
IN RESPONSE TO FOA HL-08-012 (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-08-012.html),
AND MUST ALSO HAVE PARTICIPATED IN THE DECEMBER 15, 2008, GRANTEES MEETING IN
BETHESDA, MARYLAND.

Investigators may submit only one application
as PI/PD; participation in additional applications as co-investigator is
permitted provided they are scientifically distinct. Only one Lead PI /PD
application, and only two U01 applications in total, may be derived from any
R03 application (i.e. one Lead PI/PD application and one non-Lead, or two
non-Lead PI/PD applications.

Applications
must be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a D&B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number
should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page of the application form, and the
YES box must be checked.

Prospective
applicants are asked to submit a letter of intent that includes the following
information:

Descriptive title of proposed research

Name, address, and telephone number of
the Principal Investigator

Names of other key personnel

Participating institutions

Number and title of this funding
opportunity

Although a letter of
intent is not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff to
estimate the potential review workload and plan the review.

Applications
must be prepared using the forms found in the PHS 398 instructions for
preparing a research grant application. Submit a signed, typewritten original
of the application, including the checklist, and three signed photocopies in one package to:

Applications
must be received
on or before the application receipt date) described above (Section IV.3.A.). If an application is received after
that date, the application may be delayed in the review process or not
reviewed. Upon receipt, applications will be evaluated for completeness
by the CSR and for responsiveness by the reviewing Institute incomplete and/or
non-responsive applications will not be reviewed.

The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial review, unless the
applicant withdraws the pending application. However, when a previously unfunded
application, originally submitted as an investigator-initiated application, is
to be submitted in response to a funding opportunity, it is to be prepared as a
NEW application. That is, the application for the funding opportunity must not
include an Introduction describing the changes and improvements made, and the
text must not be marked to indicate the changes from the previous unfunded
version of the application.

All NIH awards
are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at NIH Grants
Policy Statement.

Pre-award costs are allowable. A grantee may, at its
own risk and without NIH prior approval, incur obligations and expenditures to
cover costs up to 90 days before the beginning date of the initial budget
period of a new award if such costs: (1) are necessary to conduct the project,
and (2) would be allowable under the grant, if awarded, without NIH prior
approval. If specific expenditures would otherwise require prior approval, the
grantee must obtain NIH approval before incurring the cost. NIH prior approval
is required for any costs to be incurred more than 90 days before the beginning
date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project
(see NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

6. Other
Submission Requirements and Information

Instructions
for preparation of a Hub (cluster) of applications

All
applications in a Hub must share identical titles and must refer to the lead PI/PD’s
application in the cover letter. The Research Plan sections for each of the individual
applications in the Hub will describe the research project or related projects
to be carried out by that component of the Hub. The Research Plan section
for the lead PI/PD application will additionally describe the overall goals of
the Research Hub in the context of their vision for the Consortium, and the
synergistic integration of research throughout the Research Hub. The review of
the application will evaluate the entire project as a whole, the strength of
the collaborating component projects, and the synergy between the Hub
components.

Research Plan

The organization of the application will be
as described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
The Research Design and Methods section for each component application of the Hub
should propose a project or group of related projects consistent with the
objectives of the FOA and interrelated with the other applications in the Hub that
can be completed by the investigators in the Hub component in seven years.
Page limits will allow up to a total of 20 pages for the Specific Aims,
Background and Significance, Preliminary Studies, and Research Design and
Methods.

In addition, the Background and
Significance section for the application from the Lead PI for the Hub of
applications will include an additional section labeled “Research Hub
Plan,” for which up to an additional 10 pages can be used. This
section will include a discussion of the research team’s views of the
important questions facing the field of progenitor cell biology and its
application to heart, lung and/or blood diseases, and explain how their
proposed research addresses one or more of these questions. The
interactions between the individual component applications of the Hub, and the
synergies provided by the formation of a Research Hub through this cluster of
applications, should be clearly identified.

The Research Hub Plan in the Lead PI’s
application must clearly describe the management of the collaborative research.
To ensure this, it must include a management plan and identify a scientific oversight
committee. The management plan will:

Outline
plans and mechanisms to keep the project focused and progressing.

Set
intermediate milestones on a timeline to allow for the evaluation of progress
towards the project's goal.

Explain
how collaborators can be added or removed as the expertise, knowledge, and
skills necessary to advance the project change.

Describe
how intellectual property issues will be handled.

If the Multiple PI/PD approach is chosen, the
research plan will also include a Multiple PI/PD Leadership Plan.

Qualifications
and Experience

Applicants
should describe qualifications and experience in the appropriate narrative
sections of the application. Participation in the Consortium will be a
complex and time-consuming undertaking. Applicants should have an
established research program in progenitor cell biology. Research Hub PIs
will be required to declare a minimum effort of 2.4 calendar months in Section
VI. 2. A, with the exception of the Lead PI for the Hub who will be required to
declare a minimum of 3 calendar months. Applications proposing Multiple
PDs/PIs must have a minimum combined PI effort of 2.4 months, or 3 months for
the lead application for the Hub.

Collaboration

Applicants
should state their general support of collaborative research and their
willingness to participate in a collaborative and interactive manner with other
Research Hubs, the Administrative Coordinating Center, and NHLBI.

Applicants
must agree, if awarded, to accept the “Cooperative Agreement Terms and
Conditions of Award” in Section VI. 2. A.

5. Additional submission requirements
for the preparation of the Detailed Budget

Research Hubs.
All costs required for the proposed research must be included in the
application and be fully justified. The budget must include support for a
minimum of 2.4 calendar months effort for the applicant PI or a minimum of 2.4
calendar months combined effort for all PIs if the multiple PI strategy is
used. For the Lead PI application, the budget must include support for a
minimum of 3 calendar months effort for the applicant PI or a minimum of 3
calendar months combined effort for all PIs if the multiple PI strategy is used.
The Hub should identify an individual with experience in skills development who
will serve as representative on the Skills Development Committee. This
individual should declare a minimum effort of 0.6 calendar months specifically
for skills development activities, in addition to any research activities
undertaken by the individual. Applicants should budget into their applications
support for investigator skills development to be supported by the Consortium
for up to 2 years, during which time it will be expected that the supported
investigator will apply for NIH training or research grants to continue
supporting the research initiated through the Consortium. The budget should
include the costs associated with data collection, analysis, and
dissemination. Travel costs for two Steering Committee meetings per year
in Bethesda should be included for the Lead PI for the Research Hub. Core
functions that are essential for the functioning of the Research Hub should be
included within the budgets for the cluster of applications. Direct costs
cannot exceed $750,000 in any year for any application in the Hub.

Summary Budget of Each Hub.
In addition to the individual application budget, the application from the Lead
PI of each Hub must include a categorical summary budget totaling the direct
costs of the Hub.

Consortium Cores.
In addition to cores that are essential for the function of the individual
Research Hub, applicants may propose one or more core labs that they believe
would enhance the synergistic function of the Consortium, A description of the proposed
service and an estimated budget should be provided at the end of the Background
and Significance section; up to 3 additional pages may be used per core
proposed. The budget must include personnel, supplies, travel for the
core Director to one Steering Committee meeting per year in Bethesda, MD, and any other expenses. These budgets are for planning purposes only, so will be
on separate budget pages, will not be included in the proposal budget pages and
requested direct cost total, and will not be subject to the $750,000 direct
costs cap. Additional funds for the cores will be available though the
ACC (http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-09-005.html).
The NHLBI, with input from the External Advisory Committee, will determine the
Core configuration, and the ACC will allocate funds accordingly. Cores may be
phased in and out based on scientific need during the course of this FOA.

Annual Grantee Meeting: Upon initiation of the program, the ACC and NHBLI
will arrange annual meetings to encourage the exchange of information among the
investigators who participate in this program. In the preparation of the budget
for the grant application, applicants should include travel funds for one
meeting each year to be held in or near Bethesda, MD, for the Principal Investigators
and key collaborators. At these meetings awardees will be expected to share
their results and to help evaluate the progress of the Centers. Attendance at
these meetings is required.

Do
not use the Appendix to circumvent the page limitations of the Research Plan
component. An application that does not observe the required page limitations
may be delayed in the review process.

Resource
Sharing Plan(s)

NIH considers the sharing of unique research
resources developed through NIH-sponsored research an important means to
enhance the value of, and advance research. When resources have been developed
with NIH funds and the associated research findings published or provided to
NIH, it is important that they be made readily available for research purposes
to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing,
this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(b) Sharing Model Organisms:
Regardless of the amount requested, all applications where the development of
model organisms is anticipated are expectedto include a
description of a specific plan for sharing and distributing unique model
organisms and related resources, or state appropriate reasons why such sharing
is restricted or not possible. See Sharing
Model Organisms Policy, and NIH
Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless
of the amount requested, applicants seeking funding for a genome-wide
association study are expected to provide a plan for submission of GWAS data to the NIH-designatedGWAS data repository, or provide an appropriate
explanation why submission to the repository is not possible. A
genome-wide association study is defined as any study of genetic variation
across the entire genome that is designed to identify genetic associations with
observable traits (such as blood pressure or weight) or the presence or absence
of a disease or condition. For further information see Policy for Sharing
of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH
Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1.
Criteria

Only the review
criteria described below will be considered in the review process.

2. Review
and Selection Process

Applications that are
complete and
responsive to the FOA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by the NHLBI and in
accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/)
using the review criteria stated below.

As part of the scientific peer
review, all applications will:

Undergo
a selection process in which only those applications deemed to have the
highest scientific and technical merit, generally the top half of
applications under review, will be discussed and assigned a priority
score.

Receive
a written critique.

Receive a second level
of review by the National Heart, Lung, and Blood Advisory Council.

The
following will be considered in making funding decisions:

Scientific
and technical merit of the proposed project as determined by peer review

Availability
of funds

Relevance
of the proposed project to program priorities

Potential for collaboration within the Consortium, and with other
NHLBI Consortia and Networks

The
review of the application will evaluate the entire project as a whole, the
strength of the collaborating component projects, and the synergy between the Hub
components. The Hub
of applications will receive a single priority score.

The goals of NIH
supported research are to advance our understanding of biological systems, to
improve the control of disease, and to enhance health. In their written
critiques, reviewers will be asked to comment on each of the following criteria
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a meritorious priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.

Significance:Does
this study address an important problem? If the aims of the application are
achieved, how will scientific knowledge or clinical practice be advanced? What
will be the effect of these studies on the concepts, methods, technologies,
treatments, services, or preventative interventions that drive this field?

Approach:Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics? Is the leadership
approach, including the designated roles and responsibilities, governance, and
organizational structure, consistent with and justified by the aims of the
project and the expertise of each of the PDs/PIs?

Innovation: Is the project original and innovative? For
example: Does the project challenge existing paradigms or clinical practice;
address an innovative hypothesis or critical barrier to progress in the field?
Does the project develop or employ novel concepts, approaches, methodologies,
tools, or technologies for this area?

Investigators:Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the Principal Investigator and
other researchers? Does the PI/PD(s) and investigative team bring complementary
and integrated expertise to the project (if applicable)? Do the
investigators have documented experience with coordinating basic and translational
research, particularly in the areas related to progenitor cell biology?Does
the Lead PI for the Research Hub have experience in leading a collaborative
research program? Do the other PI(s) in the Hub have prior experience with
collaborative research? Does the designated Skills Development Coordinator have
well documented relevant experience?

Environment: Do(es)
the scientific environment(s) in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?

In addition to the above review criteria, the
following criteria will be applied to applications in the determination of
scientific merit and the priority score.

Potential for Collaboration:
Does the Hub provide significant synergies between the individual applications?
Do the Hub applicants have a plan for regular interactions and the
exchange of ideas? Would the project proposed benefit from collaborative
interactions with the Consortium? Will the proposal allow flexibility in
collaboration with the Consortium? Will the investigators bring valuable
areas of expertise to the Consortium that will maximize flexibility for the
program? Does the application describe prior successful collaborative
research?

Data generation and dissemination plan:
How will the anticipated data benefit the scientific community? How will
data handling and analysis benefit from collaboration with the Consortium? Will
the data be interoperable with existing resources? Will the data
collection follow accepted standards? Does the dissemination plan propose rapid
dissemination of data and resources without restrictions in regard to prior
publication by Consortium members?

Resource sharing: Does
the application indicate a willingness to share rapidly with other Consortium
members resources and reagents developed through Consortium funding?

2.A. Additional
Review Criteria:

In addition to
the above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:

Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating
to their participation in the proposed research will be assessed (see the
Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of
Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders,
all racial and ethnic groups (and subgroups), and children as appropriate for
the scientific goals of the research will be assessed. Plans for the
recruitment and retention of subjects will also be evaluated (see the Research
Plan section on Human Subjects in the PHS 398 instructions).

Care and Use
of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five points described in
the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.

2.B.
Additional Review Considerations

Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.

2.C. Resource Sharing
Plan(s)

When relevant, reviewers will be instructed to comment
on the reasonableness of the following Resource Sharing Plans, or the rationale
for not sharing the following types of resources. However, reviewers will not
factor the proposed resource sharing plan(s) into the determination of
scientific merit or priority score, unless noted otherwise in the FOA. Program
staff within the IC will be responsible for monitoring the resource sharing.

A formal
notification in the form of a Notice of Award (NoA) will be provided to
the applicant organization. The NoA signed by the grants management officer is
the authorizing document. Once all administrative and programmatic issues have
been resolved, the NoA will be generated via email notification from the
awarding component to the grantee business official (designated in item 12 on
the Application Face Page). If a grantee is not email enabled, a hard copy of
the NoA will be mailed to the business official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.

The
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official at the time of award.

2.A.
Cooperative Agreement Terms and Conditions of Award

The following special
terms of award are in addition to, and not in lieu of, otherwise applicable OMB
administrative guidelines, HHS grant administration regulations at 45 CFR Parts
74 and 92 (Part 92 is applicable when state and local governments are eligible
to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and
funding instrument used for this program will be the cooperative agreement an
"assistance" mechanism (rather than an "acquisition"
mechanism), in which substantial NIH programmatic involvement with the awardees
is anticipated during the performance of the activities. Under the cooperative
agreement, the NIH purpose is to support and stimulate the recipients'
activities by involvement in and otherwise working jointly with the award
recipients in a partnership role; it is not to assume direction, prime
responsibility, or a dominant role in the activities. Consistent with this
concept, the dominant role and prime responsibility resides with the awardees
for the project as a whole, although specific tasks and activities may be
shared among the awardees and the NIH as defined below.

2.
A.1. Principal Investigator Rights and Responsibilities

The
Principal Investigator will have the primary responsibility for all aspects of the study, including any modification of study
design, conduct of the study, quality control, data analysis and
interpretation, preparation of publications, and collaboration with other investigators,
unless otherwise provided for in these terms or by action of the Steering
Committee.

Awardee(s) agree to the
governance of the study through a Steering Committee. Steering Committee voting
membership shall consist of the Principal Investigators (i.e., cooperative
agreement awardees), the NHLBI Project Scientist, and the Chairperson, and the
ACC PI. Meetings of the Steering Committee will ordinarily be held by
telephone conference call or in the Metropolitan Washington Area.

Study investigators are
encouraged to publish and to release publicly and disseminate results and other
products of the study, in accordance with study protocols and governance.
Within three years of the end of the period of NHLBI support for the project,
data not previously released and other study materials or products not
previously distributed are to be made available to individuals who are not
study investigators, provided such release is consistent with the study
protocol and governance. In addition, study investigators must establish
a plan for making data sets and materials available to the scientific community
and to the NHLBI immediately upon completion of the three-year period following
the end of the period of NHLBI
support.

Upon completion of the
project, awardees are expected to put their intervention materials and
procedure manuals into the public domain and/or make them available to other
investigators, according to the approved plan for making data and materials
available to the scientific community and the NHLBI, for the conduct of
research at no charge other than the costs of reproduction and distribution.

Awardees will retain custody
of and have primary rights to their data developed under these awards, subject
to Government rights of access consistent with current HHS, PHS, and NIH
policies. The collaborative protocol and governance policies will call for the
continued submission of data centrally to the coordinating center for a
collaborative database; the submittal of copies of the collaborative datasets
to each Principal Investigator upon completion of the study; procedures for
data analysis, reporting and publication; and procedures to protect and ensure
the privacy of medical and genetic data and records of individuals. The NHLBI
Project Scientist, on behalf of the NHLBI, will have the same access,
privileges and responsibilities regarding the collaborative data as the other
members of the Steering Committee.

Awardees
will retain custody of and have primary rights to the data and software
developed under these awards, subject to Government rights of access consistent
with current HHS, PHS, and NIH policies.

2.
A.2. NIH Responsibilities

The NHLBI Project
Scientist will have substantial programmatic involvement that is above and
beyond the normal stewardship role in awards, as described below.

The NHLBI Project Scientist
will serve on the Steering Committee; he/she or other NHLBI scientists may
serve on other study committees, when appropriate. The NHLBI Project Scientist
(and other NHLBI scientists) may work with awardees on issues coming before the
Steering Committee and, as appropriate, other committees, e.g., data sharing
and database development, quality control, adherence to protocol, core establishment.

The NHLBI reserves the right
to withhold funding or curtail the study (or an individual award) in the event
of (a) substantive changes in the agreed-upon work scope with which NHLBI
cannot concur, (b) human subject ethical issues that may dictate a premature
termination.

Support or other involvement
of industry or any other third party in the study -- e.g., participation by the
third party; involvement of study resources or citing the name of the study or
NHLBI support; or special access to study results, data, findings or resources
-- may be advantageous and appropriate. However, except for licensing of
patents or copyrights, support or involvement of any third party will occur
only following notification of and concurrence by NHLBI.

Additionally, an agency
program official or NIH program director will be responsible for the normal
scientific and programmatic stewardship of the award and will be named in the
award notice. The assigned program director may also serve as an NIH
Project Scientist.

2.A.3.
Collaborative Responsibilities

Awardees agree to the governance of the Consortium through
the Steering Committee. Membership will include, at a minimum, the Consortium
PIs, the PI of the ACC, and the NHLBI Project Scientist. The Steering
Committee Chair will be appointed by NHLBI. Additional members may be
added by majority vote of the Steering Committee.

Awardee members of the
Steering Committee will be required to accept and implement policies approved
by the Steering Committee.

2.A.4. Arbitration Process

Any disagreements that
may arise in scientific or programmatic matters (within the scope of the award)
between award recipients and the NIH may be brought to arbitration. An
Arbitration Panel composed of three members will be convened. It will have
three members: a designee of the Steering Committee chosen without NIH staff
voting, one NIH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special
arbitration procedure in no way affects the awardee's right to appeal an
adverse action that is otherwise appealable in accordance with PHS regulations
42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

A
final progress report, invention statement, and Financial Status Report are
required when an award is relinquished when a recipient changes institutions or
when an award is terminated.

Section VII. Agency Contacts

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:

1.
Scientific/Research Contacts:

For
information about the Consortium mechanism and cardiovascular research topics:

Human Subjects Protection:Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies (Phase
I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials
(Phase III). Monitoring should be commensurate with risk. The establishment of
data and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risks to the participants
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a plan
for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, state and federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.

Policy
for Genome-Wide Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/

Access
to Research Data through the Freedom of Information Act:The Office of
Management and Budget (OMB) Circular A-110 has been revised to provide access
to research data through the Freedom of Information Act (FOIA) under some
circumstances. Data that are (1) first produced in a project that is supported
in whole or in part with Federal funds and (2) cited publicly and officially by
a Federal agency in support of an action that has the force and effect of law
(i.e., a regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has provided
guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Sharing of
Model Organisms:NIH is committed
to support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004, receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Inclusion of
Women And Minorities in Clinical Research:It is the policy
of the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a clear
and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43). All investigators proposing clinical research
should read the "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: (a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and (b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of
Children as Participants in Clinical Research:The NIH
maintains a policy that children (i.e., individuals under the age of 21) must
be included in all clinical research, conducted or supported by the NIH, unless
there are scientific and ethical reasons not to include them.

Required
Education on the Protection of Human Subject Participants:NIH policy
requires education on the protection of human subject participants for all
investigators submitting NIH applications for research involving human subjects
and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human
Embryonic Stem Cells (hESC):Criteria for
federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.

NIH Public Access Policy Requirement:In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008, to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards
for Privacy of Individually Identifiable Health Information:The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information," the "Privacy Rule," on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for the review because reviewers are
under no obligation to view the Internet sites. Furthermore, we caution
reviewers that their anonymity may be compromised when they directly access an
Internet site.

Healthy People 2010:The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not
subject to the intergovernmental review requirements of Executive Order 12372.
Awards are made under the authorization of Sections 301 and 405 of the Public
Health Service Act as amended (42 USC 241 and 284) and under Federal
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the
terms and conditions, cost principles, and other considerations described in
the NIH Grants Policy Statement. The NIH
Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of researchers
by providing the means for developing a research career unfettered by the
burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40-hour
week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.